Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200456
Company: SOFGEN PHARMS
Company: SOFGEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/28/2012 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200456Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/20/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
PROGESTERONE
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207724 | AMNEAL PHARMS NY |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 200900 | BIONPHARMA |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208801 | DR REDDYS |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211285 | EUGIA PHARMA |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 200456 | SOFGEN PHARMS |
PROGESTERONE | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 205229 | XIROMED |
PROMETRIUM | PROGESTERONE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 019781 | VIRTUS |
CAPSULE;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207724 | AMNEAL PHARMS NY |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 200900 | BIONPHARMA |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 208801 | DR REDDYS |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 211285 | EUGIA PHARMA |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 200456 | SOFGEN PHARMS |
PROGESTERONE | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 205229 | XIROMED |
PROMETRIUM | PROGESTERONE | 200MG | CAPSULE;ORAL | Prescription | Yes | AB | 019781 | VIRTUS |